FDA.reportPublic FDA data

EPINEPHRINE INJECTION

Manufacturer
Aspen Veterinary Resources®, LTD. | Sparhawk Laboratories, Inc | SYN-TECH CHEM. & PHARM. CO., LTD.
Effective date
2026-04-22
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:46:52

Label at a glance#

ProductEPINEPHRINE
Active ingredientEPINEPHRINE
Label structure6 sections

Dosage and administration

Dogs and Cats : 0.1 to 0.5 mL injected Intramuscularly or Subcutaneously. Cattle , Horses , Sheep and Swine : 1 mL per 100 lbs of body weight injected Intramuscularly or Subcutaneously.

Storage and handling

Store at controlled room temperature between 15° and 30°C (59° - 86°F) . Protect from light . TAKE TIME OBSERVE LABEL DIRECTIONS

Label contents#

Full prescribing information#

EPINEPHRINE INJECTION

INDICATIONS & USAGE SECTION

1 mg/mL

STERILE MULTIPLE DOSE VIAL

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS

For emergency use only in treating anaphylactoid shock in sheep, swine, cattle, horses, dogs and cats.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dogs and Cats: 0.1 to 0.5 mL injected Intramuscularly or Subcutaneously.

Cattle, Horses, Sheep and Swine: 1 mL per 100 lbs of body weight injected Intramuscularly or Subcutaneously.

WARNING

WARNINGS SECTION

Do not use this product if it's color is pinkish or darker than slightly yellow or if it contains a precipitate.

COMPOSITION

COMPONENTS

Each mL of sterile aqueous solution contains:

Epinephrine ....................... 1 mg

Sodium Chloride ................  0.1%

Benzyl Alcohol ..................  1.5%

Disodium Edetate, Sodium Metabisulfite, Hydrochloric Acid, and Water for Injection.

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 15° and 30°C (59° - 86°F).

Protect from light.

TAKE TIME OBSERVE LABEL DIRECTIONS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PIVETAL Epinephrine 20PIVETAL Epinephrine 20PIVETAL Epinephrine 20PIVETAL Epinephrine 20PIVETAL Epinephrine 20PIVETAL Epinephrine 20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSN1
310132epinephrine 1 MG/ML Injectable SolutionSCD1
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSY1
310132epinephrine 1:1000 Injectable SolutionSY1
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EPINEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46066-940-02EPINEPHRINE50 mL in 1 VIALINJECTION501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46066-94046066-940-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.55befbe4-c819-4367-bbe7-de5841786aac2026-09-03Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.5ba14408-c8fb-4734-aad9-ee19696acac22026-08-28Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5725a519-3ad6-7e5e-e063-6394a90a111f2026-08-10Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5726eeca-db88-ba8e-e063-6294a90a927d2026-08-03Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLCa6afb9e8-1db9-480c-8d31-58c5c870ca492026-07-29Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLC4f83895f-638c-4515-af03-7c41ae60a42e2026-07-15Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEA-S Medication Solutions6e811e28-0199-4df7-a916-5940c632401d2026-07-13Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINECIVICA, INC.4a79ad00-405b-4454-a692-7f1daac4adec2026-07-10Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEA-S Medication Solutions386519ba-7a44-4edd-9eb1-748419b7a71b2026-07-06Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLC3b7a4364-668d-4eb2-a20c-04adc35aabe42026-07-01Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEREMEDYREPACK INC.0172280c-f7d6-4613-9dbd-f94d3ae5825a2026-06-08Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEHikma Pharmaceuticals USA Inc.1e8ebac1-5b32-47f9-a930-86a98a24dccc2026-05-05Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINESportpharm LLC3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92026-04-24Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
neffyEPINEPHRINESportpharm LLC2052f9db-7d76-443b-b702-b6b499f9a4b82026-04-24Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
neffyEPINEPHRINEARS Pharmaceuticals Operations, Inc.a1758142-a905-401d-8961-05829f51023a2026-04-09Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLCa5ce0c01-dd47-4997-ab09-490de65d38352026-04-08Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLCb27e06aa-5b40-44bc-8de7-80b027580a3b2026-04-08Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
epinephrineEPINEPHRINEBaxter Healthcare Corporationef556382-9d19-4f0e-9dbe-fcecc772a3e22026-03-30Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE
epinephrineEPINEPHRINEREMEDYREPACK INC.c66de0d3-3b0f-4e52-a712-60357a1076762026-03-24Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE
epinephrineEPINEPHRINEAmneal Pharmaceuticals of New York LLCe13f05f1-7d21-49bb-b8d5-24bf9301c3d72026-03-20Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.